CClinicalTrials.gg
Sign In
Active, not recruitingNCT04581473Updated Jun 5, 2025

Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection

A Phase 1/2 interventional study of CT041 autologous CAR T-cell injection and Physician's Choice（Paclitaxel or Irinotecan or Apatinib or Anti-PD-1 antibody） in Gastric Adenocarcinoma, Pancreatic Cancer and Gastroesophageal Junction Adenocarcinoma, sponsored by CARsgen Therapeutics Co., Ltd.. Active, not recruiting at 24 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-06-05.

Sponsored by CARsgen Therapeutics Co., Ltd. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
192
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

An open, multicenter, phase Ib/II study to evaluate the efficacy, safety and pharmacokinetics of CT041 autologous CAR T-cell injection in patients with advanced gastric/ gastroesophageal junction adenocarcinoma and pancreatic cancer

Read the detailed description

This study is an open, multicenter, Phase Ib/II clinical trial evaluating chimeric antigen receptor-modified autologous T cells targeting Claudin18.2 (CLDN18.2) (CT041 autologous CAR T) in subjects with CLDN18.2 expression-positive, advanced gastric/esophagogastric conjugate adenocarcinoma that has failed at least 2 prior lines therapy and advanced pancreatic cancer that has failed at least 1 prior line therapy. The purpose is to evaluate the efficacy, safety and pharmacokinetics There are two stages in the study. Phase Ib stage is dose escalation and dose expansion study, and Phase II stage is to verify the efficacy and safety of CT041 treatment.

02

Conditions studied

  • Gastric Adenocarcinoma
  • Pancreatic Cancer
  • Gastroesophageal Junction Adenocarcinoma

Keywords

  • advanced solid tumors
  • Gastric Cancer
  • Pancreatic Cancer
  • Esophagogastric Junction Cancer
  • Claudin18.2
  • CLDN18.2
  • CAR T cell
03

In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.

This study's planned enrollment of 192 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

CARsgen Therapeutics Co., Ltd. is the lead sponsor of 13 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Be willing to participate in a clinical trial, be informed and sign inform consent; and be willing to follow and be able to complete all trial procedures;
  2. Aged 18 to 75 years;
  3. Phase Ib：Patients with pathologically diagnosed advanced gastric/ gastroesophageal junction adenocarcinoma who have failed at least 2 prior lines treatment; or patients with pathologically diagnosed advanced pancreatic cancer who have failed at least 1 prior line treatment ; Phase II：Patients with pathologically diagnosed advanced gastric/ gastroesophageal junction adenocarcinoma who have failed at least 2 prior lines treatment;
  4. Phase Ib：Tumor tissue samples were positive for CLDN18.2 IHC staining； Phase II：Tumor tissue samples were positive for CLDN18.2 IHC staining and HER2 expression was negative;
  5. Estimated life expectancy >12 weeks;
  6. According to the RECIST 1.1, there is measurable tumor lesions;
  7. ECOG physical status score 0 \~ 1 at screening, within 24 hours prior to apheresis, and at baseline;
  8. Sufficient venous access for mononuclear cell collection;
  9. Unless otherwise specified, patients should meet the certain conditions prior to screening and pre-treatment and be allowed one week to retest if an abnormal laboratory test does not meet the criteria, and if the criteria are still not met, the screening is considered to have failed;
  10. Female patients of childbearing age must undergo a serum pregnancy test at screening and prior to pretreatment and the results must be negative, and are willing to use a very effective and reliable method of contraception within 1 year after the last study treatment;
  11. Men who have actively sexual intercourse with women with child-bearing potential, must agree to use barrier-based contraception if they have no vasectomy.

Exclusion criteria

Exclusion Criteria:

  1. Pregnant or lactating women;
  2. HIV, Treponema pallidum, HCV serologically positive, EBV-DNA, CMV-DNA or 2019-ncov nucleic acid positive;
  3. Any uncontrollable active infection, including but not limited to active tuberculosis, HBV infection;
  4. The side effects caused by the previous treatment of the subjects did not return to CTCAE ≤1; except hair loss and other tolerable events determined by investigator;
  5. Patients known to have active autoimmune diseases, including but not limited to psoriasis or rheumatoid arthritis, or other diseases requiring long-term immunosuppressive therapy;
  6. Previously allergic to immunotherapy and related drugs,history of severe allergies, or allergic to components of CT041.
  7. Previously received any gene-modified cell therapies(including CAR-T, TCR-T);
  8. Patients have brain metastasis or symptoms of brain metastasis;
  9. Patients at high risk of hemorrhage or perforation;
  10. Patients requiring anticoagulant therapy;
  11. Patients requiring continuous anti-platelet therapy;
  12. Patients with a history of organ transplantation or awaiting organ transplantation;
  13. Patients who have undergone major surgery or significant trauma within 4 weeks prior to apheresis, or who are expected to undergo major surgery during the study;
  14. Presence of other serious pre-existing medical conditions that may limit patient participation in the study;
  15. The investigator assessed that the patient was unable or unwilling to comply with the requirements of the study protocol;
  16. The patient has a central nervous system disease sign or an abnormal neurological test result with clinical significance;
  17. The patient is currently suffered from or have suffered from other incurable malignant tumors within previous 3 years, except in situ cervical cancer or skin basal cell cancer.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
192 participants (estimated)

Study arms

  • Experimental
    CT041 autologous CAR T-cell injection

    Two stages: Phase 1b: dose escalation and dose expansion; Phase 2: verify CT041 efficacy and safety

    Drug: CT041 autologous CAR T-cell injection

  • Active comparator
    Physician's Choice

    Participants will receive physician's choice of treatment in Phase II

    Drug: Physician's Choice（Paclitaxel or Irinotecan or Apatinib or Anti-PD-1 antibody）

Interventions

  • DrugCT041 autologous CAR T-cell injection

    Up to 3 times CT041 autologous CAR T-cell injection infusion

    Also known as: CAR T-cell injection

  • DrugPhysician's Choice（Paclitaxel or Irinotecan or Apatinib or Anti-PD-1 antibody）

    Physician's choice of any BSC listed above

    Also known as: Best support care(BSC)

06

What researchers measure

Primary outcomes

  1. Phase Ib: Incidence of Treatment Related adverse events (AEs)

    Incidence of treatment related AEs, AEs of special interest and serious adverse events(SAEs).

    Time frame: Up to 18 months

  2. Phase Ib: Identification of Maximum Tolerated Dose (MTD)

    Incidence of dose-limiting toxicities (DLTs)

    Time frame: day1-day28

  3. Phase II: Progression-free survival (PFS), as assessed by IRC, of CT041 autologous CAR T-cell injection versus Physician's Choice

    Progression-free survival (PFS) was defined as the time from the date of randomization to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause.

    Time frame: Up to 24 months

Secondary outcomes

  1. Phase Ib: Objective Response Rate (ORR), as assessed by Investigators

    The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1.

    Time frame: Up to 18 months

  2. Phase Ib: Progression-free survival (PFS), as assessed by Investigators

    Progression-free survival (PFS) was defined as the time from the date of first infusion of CT041 to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause.

    Time frame: Up to 18 months

  3. Phase Ib：Overall survival (OS)

    Overall Survival (OS) was defined as the time from the date of first infusion of CT041 to the date of death due to any cause.

    Time frame: Up to 18 months

  4. Phase Ib：Duration of response (DOR), as assessed by Investigators

    Duration of response (DOR) is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death.

    Time frame: Up to 18 months

  5. Phase Ib：Disease control rate (DCR), as assessed by Investigators

    Disease control rate (DCR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1.

    Time frame: Up to 18 months

  6. Phase II: Overall survival (OS) of CT041 autologous CAR T-cell injection versus Physician's Choice

    Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause.

    Time frame: Up to 24 months

  7. Progression-free survival (PFS), as assessed by Investigators, of CT041 autologous CAR T-cell injection versus Physician's Choice

    Progression-free survival (PFS) was defined as the time from the date of randomization to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause.infusion

    Time frame: Up to 24 months

  8. Phase II：Objective Response Rate (ORR), as assessed by IRC and by Investigators

    The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1.

    Time frame: Up to 24 months

  9. Phase II: Duration of response (DOR), as assessed by IRC and by Investigators

    Duration of response (DOR) is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death.

    Time frame: Up to 24 months

  10. Phase II: Disease control rate (DCR), as assessed by IRC and by Investigators

    Disease control rate (DCR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1.

    Time frame: Up to 24 months

07

Study locations

24 sites
  • Anhui Provincial Cancer Hospital
    Hefei, Anhui, China
  • Beijing Cancer Hospital
    Beijing, Beijing 100142, China
  • Fujian Medical University Union Hospital
    Fuzhou, Fujian, China
  • Peking University Shenzhen Hospital
    Shenzhen, Guangzhou, China
  • Harbin medical university Affiliated Cancer Hospital
    Harbin, Heilongjia, China
  • Henan Tumor Hospital
    Zhengzhou, Henan, China
  • The First Affiliated Hospital of Zhengzhou University
    Zhengzhou, Henan, China
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
    Wuhan, Hubei, China
  • Nanjing Drum Tower Hospital
    Nanjing, Jiangsu, China
  • The Second Affiliated Hospital of Soochow University
    Suzhou, Jiangsu, China
  • Northern Jiangsu People's Hospital
    Yangzhou, Jiangsu, China
  • The Second Affiliated Hospital of Nanchang University
    Nanchang, Jiangxi, China
  • The First Hospital of Jilin University
    Changchun, Jilin, China
  • The First Hospital of China Medical University
    Shenyang, Liaoning, China
  • Shandong Cancer Hospital
    Jinan, Shandong, China
  • The Affiliated Hospital of Qingdao University
    Qingdao, Shandong, China
  • Ruijin Hospital, affiliated to Shanghai Jiaotong University, school of medicine
    Shanghai, Shanghai 200025, China
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai 200032, China
  • Shanghai Zhongshan Hospital
    Shanghai, Shanghai, China
  • Sichuan Cancer Hospital
    Chengdu, Sichuan, China
  • West China Hospital, Sichuan University
    Chengdu, Sichuan, China
  • Tianjin Medical University Cancer Institute and Hospital
    Tianjin, Tianjin 300060, China
  • The First Affiliated Hospital, Zhejiang University School of Medicine
    Hangzhou, Zhejiang, China
  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
    Hanzhou, Zhejiang, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04581473
Lead sponsor
CARsgen Therapeutics Co., Ltd.
Collaborators
Peking University Cancer Hospital & Institute, Fudan University
Responsible party
Sponsor
First posted
Oct 9, 2020
Start date
Oct 23, 2020
Primary completion
Oct 18, 2024
Completion
Jun 30, 2038 (estimated)
Last update
Jun 5, 2025

Study contacts

Lin Shen, Professor
principal investigator · Peking University Cancer Hospital & Institute
Xianjun Yu, Professor
principal investigator · Fudan University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Adenocarcinoma→

Other studies from this sponsor

CARsgen Therapeutics Co., Ltd.

Start the discussion